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The U.K.’s National Institute for Health and Care Excellence (NICE) has issued a preliminary rejection of Bristol-Myers Squibb’s Opdivo (nivolumab) and Yervoy (ipilimumab) as a combination treatment for lung cancer in as-yet untreated patients. Read More
Emergent BioSolutions’ beleaguered Baltimore, Md., facility, which Johnson & Johnson has taken over to exclusively produce its vaccine, may be cleared to start shipping out J&J doses before the month is over, according to the White House’s COVID-19 response leader. Read More
The Biden administration has sent a budget proposal to Congress, outlining its spending priorities for fiscal year 2022, but it sheds almost no light on the president’s plans to fund FDA initiatives. Read More
The FDA has released minutes from its meetings in early 2021 with industry on PDUFA reauthorization, discussions that focused on the agency’s Sentinel drug surveillance system and proposed Risk Evaluation and Mitigation Strategies (REMS) assessments. Read More
The commission is inviting comments on the roadmap by April 27, but a public consultation on the strategic plan will continue through the end of this year. Read More
Companies who wish to participate in the ILAP must apply for an “Innovation Passport” and provide details of why their product should be considered for the pathway. Read More
In an effort to fund his massive $2 trillion plan to overhaul U.S. infrastructure, President Biden is proposing to come down hard on corporations with heavier taxes — and his tax strategy includes provisions to eliminate current overseas tax breaks and havens that would have a significant impact on the pharma industry. Read More
The case arose from a 2013 whistleblower lawsuit filed in the Eastern District of Pennsylvania by attorney and pharma activist Ronald Streck. Read More
In public comments, industry trade associations have largely welcomed the FDA’s efforts thus far to improve its process for reviewing and approving biosimilars under the Biosimilar User Fee Amendments (BsUFA) II program. Read More
The FDA has issued a Complete Response Letter (CRL) to San Diego, Calif.-based Acadia Pharmaceuticals for their supplemental New Drug Application for Nuplazid (pimavanserin) for the treatment of hallucinations and delusions associated with dementia-related psychosis (DRP). Read More